Hypersensitivity reactions including acute infusion reaction, anaphylactic/anaphylactoid reaction & angioedema. Discontinue treatment in case of hypersensitivity reactions; confirmed diagnosis of ILD. Interrupt treatment in pending diagnostic evaluation of new or progressive dyspnoea, cough & fever. Withhold treatment if neutropenic fever occurs or ANC drops <1,500 cells/mm
3. Not to be used in patients w/ severe bone marrow failure; bowel obstruction & chronic inflammatory bowel disease. Not to be interchanged w/ other non-liposomal irinotecan formulations. Early (≤24 hr) or late (>24 hr) onset of diarrhoea; delay treatment until diarrhoea resolves to Grade 1 (2-3 stools/day more than pre-treatment frequency). Reduce dose following Grade 3 or 4 diarrhoea. Early onset diarrhoea accompanied by cholinergic symptoms eg, rhinitis, increased salivation, flushing, diaphoresis, bradycardia, miosis & hyperperistalsis. Sepsis w/ neutropenic fever & consequent septic shock; thromboembolic events eg, pulmonary embolism, venous thrombosis & arterial thromboembolism; ILD. History of abdominal radiation; Whipple procedure. Severe haematological events. Pre-existing lung disease, use of pneumotoxic medicinal products, colony stimulating factors or previous RT. Patients w/ deficient glucuronidation of bilirubin eg, those w/ Gilbert's syndrome; receiving concomitant irradiation therapy. Underwt patients w/ BMI <18.5 kg/m
2. Asian patients. Monitor CBC during treatment; signs of infection. Closely monitor for resp symptoms before & during therapy in patients w/ risk factors of ILD. Monitor & replace fluid electrolytes, stop loperamide, & continue antibiotic support if diarrhoea persists >48 hr. Not to be administered w/ strong CYP3A4 inducers eg, anticonvulsants (phenytoin, phenobarb, carbamazepine), rifampin, rifabutin & St. John's wort; CYP3A4 inhibitors (eg, grapefruit juice, clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole); UGT1A1 inhibitors (eg, atazanavir, gemfibrozil, indinavir). Avoid administration of live or live-attenuated vaccines in immunocompromised patients. May affect ability to drive & use machines. Not recommended in severe renal impairment (CrCl <30 mL/min). Pre-existing hepatic impairment (bilirubin >2x ULN; transaminases >5x ULN). Males should use effective contraception during treatment & 4 mth thereafter. Women of childbearing potential should use effective contraception during treatment & 7 mth thereafter. Pregnancy. Not to breastfeed until 1 mth after last dose. Childn & adolescents ≤18 yr.
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